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Exemptions Biotechnology

Wiley Rein LLP

Five Key Takeaways From EPA’s Biotech PIPs Exemption Proposed Rule

Wiley Rein LLP on

On October 9, the U.S. Environmental Protection Agency (EPA) published for public comment its long-awaited proposed rule to exempt from most requirements of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)...more

Hogan Lovells

European Medicines Agency’s clarification regarding re-testing exemption for imported advanced therapy medicinal products

Hogan Lovells on

On 21 August 2019, the European Medicines Agency (EMA) published questions and answers regarding imported advanced therapy medicinal products (ATMP). The document focuses on the possibility of batch controls exemption for...more

Manatt, Phelps & Phillips, LLP

Agreement Reached on Bipartisan Federal GMO Food Labeling Bill

Provides Practical, Mandatory Disclosure and Preempts State GMO Labeling Laws - Senate Agriculture Committee leaders reached agreement June 23, 2016, on a bill that would require food containing genetic material modified...more

McDonnell Boehnen Hulbert & Berghoff LLP

MBHB Snippets: Review of Developments in Intellectual Property Law - Winter 2013 - Volume 11, Issue 1: Federal Courts Debate Safe...

Patent protection is a critical driver of value for the biotech industry. One of the unique aspects of biotech patents, however, is that many otherwise infringing activities are exempt from claims of patent infringement when...more

McDonnell Boehnen Hulbert & Berghoff LLP

MBHB Snippets: Review of Developments in Intellectual Property Law - Winter 2013 - Volume 11, Issue 1

In This Issue: Federal Courts Debate Safe Harbor Exemption for Patent Infringement Under 35 U.S.C. § 271(e) Following Merck v. Integra; If I Prioritize Examination of My Application, Should the Patent Office?;...more

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